post-marketing surveillance of hiv-infected patients with chronic hepatitis c treated with pegintron pen and rebetol (study p04584)

Conditions: Chronic Hepatitis C; Hepatitis C; HIV Infections

Summary: the objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (peg-ifn alfa-2b) and ribavirin (rbv) administered to participants coinfected with human immunodeficiency virus (hiv) and hepatitis c virus (hcv). participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. the study assessed the rates of eradication of the hcv and the rates of serious adverse events reported with peg-ifn alfa-2b (1.5 ug/kg/week) and rbv (800-1200 mg/day) in common medical practice in germany.

in this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. no investigational medicinal product was provided by the sponsor.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age eligible for treatment according to the summary of product characteristics (smpc) * presence of chronic hepatitis c (with elevated liver enzymes and without decompensation) * presence of hcv-rna and known genotype of the infecting hepatitis c virus * hiv infection confirmed by positive enzyme linked immunosorbent assay (elisa) and western blot and cluster of differentiation (cd) 4 cell count \>200/ml * treatment-naïve * platelets ≥ 75,000/mm\^3 * neutrophil counts ≥ 1,500/mm\^3 * thyroid stimulating hormone (tsh) must be within normal limits * hemoglobin ≥ 10 g/dl (females); ≥ 11 g/dl (males) * women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment. * sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment. exclusion criteria: * contraindications according to the european approval and to the smpc * pretreatment of chronic hepatitis c * liver decompensation * hypersensitivity to the active substance or to any interferons or to any of the excipients * pregnant woman * women who are breast feeding * existence of or history of psychiatric condition, particular depression, suicidal ideation or suicide attempt * a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months * severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \< 50 ml/min. * autoimmune hepatitis or history of autoimmune disease * severe hepatic dysfunction or decompensated cirrhosis of the liver * pre-existing thyroid disease unless it can be controlled with conventional therapy * epilepsy and/or compromised central nervous system function

Keywords: hiv